Modified Use for Model 6110A Iontophoretic Appli.
FDA 510(k) K871869 · Life-Tech Intl., Inc.
510(k) numberK871869
Submission
- Device name
- Modified Use for Model 6110A Iontophoretic Appli.
- Applicant
- Life-Tech Intl., Inc.
Houston, TX, US - Received
- May 13, 1987
- Decision date
- August 11, 1987
- Decision
- Unknown (SESD)
- Type
- Traditional 510(k)
Device classification
- Product code
- EGJ – Device, Iontophoresis, Other Uses
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5525
- Specialty
- Physical Medicine
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| K170835 | Electro Antiperspirant, Electro Antiperspirant Sensitive, Electro Antiperspirant ELITEEGJ · Traditional | Hightech Development | 06/15/2018SE |
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| K150453 | TULA Iontophoresis System with EarsetEGJ · Special | Acclarent, Inc. | 05/20/2015SE |
| K133033 | Hidrex PSP1000EGJ · Traditional | Hidrex GmbH | 04/08/2015SE |
| K132832 | Activapatch Et Iontophoresis PatchEGJ · Traditional | Activatek, Inc. | 02/13/2014SE |
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| K946108 | Ear-A-GatorKHH · Traditional | 06/13/1995SE |
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Questions and answers
When was Modified Use for Model 6110A Iontophoretic Appli. cleared by the FDA?
Modified Use for Model 6110A Iontophoretic Appli. (K871869) received a 510(k) decision of Unknown on August 11, 1987, 90 days after the submission was received.
What is the product code of K871869?
The FDA product code is EGJ – Device, Iontophoresis, Other Uses, a Class II (moderate risk) device regulated under 21 CFR 890.5525.